The research and application of this technology occupy an extremely important position in medical and health practice and industrial practice, and play a role in promoting the development of medical and pharmaceutical sciences. In recent years, as new pharmaceutical preparations have become the growth point of the pharmaceutical industry, sales of new drug delivery systems worldwide have grown steadily, accounting for more than 10% of the entire pharmaceutical market. New treatment concepts have promoted the development of new drug delivery systems, and new technologies have promoted the launch of new formulation products. The laser particle size analyzer is playing an increasingly important role in the research and production of pharmaceutical preparations, and has been valued by engineering and technical personnel and drug inspectors in the quality identification and control of pharmaceutical preparation research and production processes. The following is a discussion of the application of particle laser detection technology in the research and production of new formulations.
1. Microcapsule:
The micro-encapsulation technology is a rapidly developing, widely used and mature technology in today's world. The process of preparing microcapsules is called microencapsulation, which is to encapsulate solid, liquid or gas in a tiny capsule. The particle size of the microcapsules is different due to different preparation processes and uses. Theoretically, microcapsules of 0.1 to 1000 nm can be made, which can be divided into microcapsules and nanoscale nanocapsules. There are three types of preparation of microcapsules: physical chemical method, physical mechanical method and chemical method. Among them, the phase separation process in physicochemical method has now become one of the main processes of drug microencapsulation. This process still involves some quality problems that cannot be quantitatively studied and are difficult to accurately evaluate, such as the common problems of microcapsule adhesion and aggregation. Products obtained by similar processes differ greatly in particle size range and release data. With the LS laser particle measurement method, the particle size and distribution of the sample can be observed more intuitively. The more concentrated the distribution, the more uniform it is (Figure). Through this test, you can find out whether the process is reasonable and whether it is strictly controlled. Whether the sensitivity of the microencapsulation reaction is appropriate, and small changes in the conditions will cause a significant difference in effect to achieve controllability. For example, the process of using gelatin as a bladder material.
If the concentration of the diluent used is too high or too low, the coagulation vesicles can stick together or dissolve.
2. Microspheres
Microspheres (microspheres) refer to a dispersion system of particles formed by drug dispersion or adsorption in a polymer matrix. The drug can be dissolved or dispersed in the base layer of the polymer material to form a solid skeleton of the base-type tiny spherical entity. The particle size is generally 1 ~ 300μm, or even larger. In addition, a solid medicine or liquid medicine is wrapped as a capsule heart to form a medicine warehouse type microcapsule, called a microcapsule. There is no strict distinction between the two. The particle size of the microspheres varies (0.01 ～ 700μm). Except for microscopy and electron microscopy, the detection methods are laser particle size measurement and Coulter counter. Laser particle size analysis is more extensive than the first two methods reflect. The microscope is limited to the field of view, and the scope observed by the electron microscope is smaller, and the particle morphology can only be observed more finely. From the perspective of formulation research and production, laser particle size analysis and Coulter calculation can better guide the process and reflect the quality.
3. Powder aerosol (powderinhalation)
Powder aerosol is one or more drugs. After being administered by a special drug delivery device, it enters the respiratory tract in the form of dry powder and exerts systemic or local effects. Small features. According to the different administration sites, it can be divided into nasal powder aerosol and transoral (pulmonary inhalation) powder aerosol. The characteristics of powder aerosols are: ①no gastrointestinal degradation; ② no liver first-pass effect; ③ rapid drug absorption, rapid effect after administration; ④ bioavailability of macromolecular drugs can be through absorption promoters or other methods Application; ⑤Small molecule drugs are especially suitable for direct inhalation or spray administration of the respiratory tract; ⑥The drug enters the circulation directly after absorption to achieve the purpose of systemic treatment; ⑧ The patient has good compliance, especially suitable for patients who need to be treated with long-term injection; ⑨ The drug that acts locally, the dosage is significantly reduced, and the side effects are few. Different administration sites have different requirements for the particle size. For example, lung inhalation powders require that the particle size of the main drug should be less than 5 μm, while the particle size of nasal powders should be 30 to 150 μm. The quality study of powder aerosol is particle quality inspection. Mainly check the particle size distribution, particle morphology, determine these items, LS laser particle size analyzer is more suitable.
4. The size and distribution of liposomes
The size and uniformity of liposome particle size are related to its encapsulation rate and stability, which directly affect the behavior and disposal of liposomes in the body tissues. The size of liposomes is less than 100nm, and the circulation time is longer. If the size of liposomes is greater than 200nm, the liposomes are easily engulfed by macrophages as foreign bodies, and the circulation time of liposomes in the body very short. There are many factors that affect the size and distribution of liposomes. It can be considered that all factors that affect the stability of liposome coalescence are related to the size and distribution of liposomes. For the inspection of liposomes, the particle size of liposomes can be quickly and simply displayed by laser particle size analysis. The average particle size and median particle size can be measured. The distribution chart can determine whether the particles are uniform and stable.
5. Liposomal ophthalmic medicine system
Liposomes are used as an eye drug delivery system. The material of the liposome is a bilayer membrane of phospholipid, similar to a biofilm. It is easy to be fused with a biomembrane and promotes the penetration of drugs into the biofilm. High; by choosing different preparation methods, the liposomes are made with a particle size of 0.02 ~ 5μm, dripping into the eye without foreign body sensation, does not affect the normal physiological function of the eye.
The preparation of liposome ophthalmic drug delivery system is similar to that of general liposomes. Quality control—Using the laser particle size analyzer, samples should be analyzed after homogenization.
6. Stability of the new emulsion
Emulsions are two immiscible liquids that are emulsified by a surfactant to disperse one liquid in another liquid to form an uneven micro- or nano-dispersed system. Microscopic examination of the emulsion within this range, the use of laser particle size analyzer can determine the size and distribution of emulsion particles. The size and number of particles in each particle diameter interval can be analyzed through 116 analysis channels; the overall distribution and uniformity of particles can be observed through the particle distribution map; and commonly used technical parameters can also be collected through the statistical chart of the distribution map.
7. Nanoparticles
It is generally believed that the particle size of the nanoparticles is defined in the range of 1 to 1000 nm. Researched nanoparticles include polymer nanoparticles and nanospheres, drug bodies, lipid nanoparticles, nanoemulsions and polymer capsules.
For example: the liquid paraffin used in the oil phase can be made into nanospheres with an average particle size of 820nm
The average particle size of the nanospheres made from cottonseed oil is 560nm.
Summary: With the rapid development of pharmaceutical preparation technology, new preparations are gradually transferred from laboratories to pharmaceutical production enterprises. The application of laser particle size analysis in process control and drug quality control is also becoming more and more important. Understanding and mastering the laser particle size analysis method to welcome the new era of pharmaceutical preparations will benefit us.
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